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Instructor Class Description

Time Schedule:

Sara Magee
PHRMRA 545
Seattle Campus

Data Essentials and Analysis for Regulatory Professionals

Applies statistical methods to medical products design, clinical evaluation, manufacturing, and post-marketing surveillance. Prerequisite: introductory statistics. Offered: Sp.

Class description

Applies statistical methods (numerical emphasis) to medical products design, clinical evaluation, manufacturing, and post-marketing surveillance. Prerequisite: introductory statistics

Student learning goals

Students will understand the importance of quantification and analysis in the creation of regulatory submissions and regulatory support of medical device products, drugs and biologics for manufacturing, laboratory and clinical applications.

General method of instruction

Recommended preparation

Class assignments and grading


The information above is intended to be helpful in choosing courses. Because the instructor may further develop his/her plans for this course, its characteristics are subject to change without notice. In most cases, the official course syllabus will be distributed on the first day of class.
Last Update by Sara Magee
Date: 01/02/2014